Pexeva

OVERDOSE

Human Experience

Since the introduction of paroxetine in the US, 342
spontaneous cases of deliberate or accidental overdosage during paroxetine
treatment have been reported worldwide (circa 1999). These include overdoses
with paroxetine alone and in combination with other substances. Of these, 48
cases were fatal and, of the fatalities, 17 appeared to involve paroxetine
alone. Eight fatal cases which documented the amount of paroxetine ingested
were generally confounded by the ingestion of other drugs or alcohol or the
presence of significant comorbid conditions. Of 145 non-fatal cases with known
outcome, most recovered without sequelae. The largest known ingestion involved
2000 mg of paroxetine (33 times the maximum recommended daily dose) in a
patient who recovered.

Overdosage Management

No specific antidotes for paroxetine are known. Treatment
should consist of those general measures employed in the management of
overdosage with any drugs effective in the treatment of MDD.

Ensure an adequate airway, oxygenation, and ventilation.
Monitor cardiac rhythm and vital signs. General supportive and symptomatic
measures are also recommended. Induction of emesis is not recommended.

Due to the large volume of distribution of this drug,
forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely
to be of benefit.

A specific caution involves patients who are taking or
have recently taken paroxetine who might ingest excessive quantities of a
tricyclic antidepressant. In such a case, accumulation of the parent tricyclic
and/or an active metabolite may increase the possibility of clinically
significant sequelae and extend the time needed for close medical observation
(see Drugs Metabolized by Cytochrome CYP2D6 under PRECAUTIONS).

In managing overdosage, consider the possibility of
multiple drug involvement. The physician should consider contacting a poison
control center for additional information on the treatment of any overdose.
Telephone numbers for certified poison control centers are listed in the Physicians'
Desk Reference (PDR).

CONTRAINDICATIONS

The use of MAOIs intended to treat psychiatric disorders
with PEXEVA® or within 14 days of stopping treatment with PEXEVA® is
contraindicated because of an increased risk of serotonin syndrome. The use of
PEXEVA® within 14 days of stopping an MAOI intended to treat psychiatric disorders
is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION).

Starting PEXEVA® in a patient who is being treated with
MAOIs such as linezolid or intravenous methylene blue is also contraindicated
because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE
AND ADMINISTRATION).

Concomitant use in patients taking thioridazine is
contraindicated (see WARNINGSandPRECAUTIONS).

Concomitant use in patients taking pimozide is
contraindicated (seePRECAUTIONS).

PEXEVA® (paroxetine mesylate) tablets are contraindicated
in patients with a hypersensitivity to paroxetine or any of the inactive
ingredients in PEXEVA® (paroxetine mesylate) tablets.

Last reviewed on RxList: 11/24/2014
This monograph has been modified to include the generic and brand name in many instances.